Neuromodulation and Neurorehabilitation for mTBI

Not Applicable

Recruiting

• Conditions: Post Traumatic Stress Disorder; Mild Traumatic Brain Injury

• Registration Number: NCT03819608
• Lead Sponsor: Northwestern University

Brief Summary

This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI +/- PTSD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Study Start: 2021-04-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• At least 18 years of age and no older than 80 years of age
• 3 months post exposure to mTBI event
• Have a history of mTBI with PTSD OR mTBI without PTSD as defined by formalized measures to classify mTBI based on the Symptom Attribution and Classification Algorithm (SACA) and the PTSD Module L of the SCID
• Endorse at least moderate severity on at least one of the four cognitive complaints in the Neurobehavioral Symptom Inventory

Exclusion Criteria

• Participating in another research study
• Non-fluent in English (speaking and reading)
• History of epilepsy pre-injury
• Receiving antiepileptic treatment for documented active seizures in the past 6 months
• Taking medications that lower seizure threshold including antipsychotics, trazodone and tramadol
• History of surgery on blood vessels in brain and/or valves of the heart
• History of brain hemorrhage, neurovascular conditions and neurodegenerative disorders
• History or current diagnosis of psychotic spectrum disorders (i.e. bipolar, schizophrenia)
• Significant heart disease as determined by physician review of medical chart
• Pregnant at time of enrollment or any time during study participation
• MRI or TMS/iTBS contraindications such as claustrophobia, metal in eyes/face or brain
• Cardiac pacemakers/defibrillators, cochlear implants, nerve stimulators, intracranial metal clips
• Diagnosis of moderate or severe TBI (loss of consciousness > 30 minutes, alteration of consciousness > 24 hours, post traumatic amnesia or neuropsychological testing results
• Prescribed dosage of mental health medications have been altered within the month preceding study screening. Any participant whose mental health medication(s) has/have changed, within 30 days of study screening. The following are considered a medication change: the addition of or discontinuation of medication, a change in the dose or dosage (daily amount) of medication.
• Taking prescribed CNS stimulants and choosing to not stop these medications during study participation
• Taking prescribed CNS stimulants and choosing to not stop these medications during study participation
• Testing positive for opiates and do not have a prescription for opiates. If on prescription opiates and taking more than the equivalent of 200 mg of morphine per day.
• Questionably valid test performance as indicated by a score of ≤ 85% on the Immediate Recognition, Delayed Recognition or Consistency Scales of the Medical Symptom Validity Test (MSVT) and clinical determination of questionable performance validity by a neuropsychologist on the research team
• Actively suicidal as evidenced by plan to harm or recent attempt communicated on the Structured Clinical Interview for DSM-V (SCID-5).
• Increased Intracranial Pressure (ICP) as evidenced through a funduscopic evaluation or on the baseline MRI scan.
• Moderate or severe cannabis use disorder defined by ≥ 4 symptoms on the SCID-5
• Severe alcohol use disorder defined by ≥ 6 symptoms on the SCID-5
• Baseline systolic BP greater or equal to 170

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change in the Mayo Portland Adaptability Inventory (MPAI)	baseline, 5 weeks, 10 weeks, 20 weeks	Self-reported ability, adjustment and community participation. It is comprised of 30 items and three subscales: Ability Index, Adjustment Index and Participation Index. Items are scored on a 5-point Likert scale, with lower scores indicating higher levels of functioning.

Secondary Outcome Measures

Name	Time	Method
change in the PTSD Checklist (PCL)	baseline, 5 weeks, 10 weeks, 20 weeks	20-item self-report measure assessing the distress associated with PTSD symptoms. The higher the score, the worse the symptoms.

Trial Locations

Locations (2)

Moody Neurorehabilitation Institute; 🇺🇸 Houston, Texas, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States